Nulliparous Women Who Scheduled for Labor Induction
Conditions
Keywords
Cervical ripening, Dinoprostone, Labor induction, Membrane sweeping, Nulliparous women, Trial
Brief summary
To compare concurrent membrane sweeping with dinoprostone versus dinoprostone in labor induction for nulliparas at term with an unfavorable cervix
Interventions
PROCEDUREConcurrent membrane sweeping with Dinoprostone
Women assigned to Sweep had their cervix swept by inserting the examining finger as high as possible past the internal cervical os, immediately followed by the placement of a 10mg Dinoprostone vaginal insert in the posterior fornix.
DRUG10mg Dinoprostone vaginal insert
For women assigned to No sweep: The only 10mg Dinoprostone vaginal insert were placed in the posterior fornix for cervical ripening
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* singleton pregnancy * Nulliparous women * gestational age \>=37.0 weeks * Bishop score \<=6 * intact amniotic membrane * absence of labor * live fetus with vertex presentation * no previous uterine surgical procedure
Exclusion criteria
* Multiple pregnancy * Placenta previa
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal delivery within 24 hours | Twenty-four hours of initiating intervention (i.e. membrane sweeping or PG) on the first day of induction | Vaginal delivery within 24 hours is defined as vaginal delivery after 24 hours of initiating intervention (i.e. concurrent membrane sweeping with dinoprostone or only dinoprostone) on the first day of induction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cervical change in the bishop scores and cervical lengths | Initiation of oxytocin after removing dinoprostone vaginal insert | 1. Cervical change based on the bishop score and cervical length induced by two cervical ripening methods(concurrent membrane sweeping with dinoprostone vs. dinoprostone) 2. Incidence of cesarean delivery 3. Successful labor induction (defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of \>=4cm). 4. The interval from start of oxytocin to delivery 5. Incidence of rupture of membranes 6. Incidences of vaginal bleeding and fever |
Countries
South Korea
Outcome results
None listed